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CompletedNCT02759653NOR-PLAQUpdated Feb 15, 2021

Norwegian Carotid Plaque Study

An observational study in Ischemic Stroke, Carotid Artery Disease and Embolic Stroke, sponsored by Haukeland University Hospital. Completed at 1 site in Norway. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2021-02-15.

Sponsored by Haukeland University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
16
Ages
15 Years and older
Sex
All
01

Study summary

BACKGROUND: In 30-40% the cause of ischemic stroke remains undetermined. Most likely, this category hides an additional number of strokes caused by artery-to-artery embolisms due to unidentified atherosclerotic disease, or caused by cardioembolism. Both types are associated with a high risk of recurrent ischemic events and multiple cerebral infarctions.

Large-artery atherosclerosis of the brain-supplying arteries is the assumed underlying cause in 10 to 15% of ischemic stroke, mostly deriving from the extracranial carotid artery. Carotid intima-media thickness (cIMT) measured by 2-dimensional (2D) B-mode ultrasonography and estimation of the overall atherosclerotic plaque burden aids future risk prediction. Arterial wall changes, artery caliber variations, degree of stenosis, local hemodynamic alterations and certain plaque characteristics are important for the evaluation of plaque vulnerability and vascular risk stratification. Transcranial Doppler monitoring (TCDM) is a non-invasive bedside examination eligible for detection of microemboli in the human cerebral circulation.

HYPOTHESIS: Atherosclerotic stenosis and plaque characteristics can be more accurately assessed by the combination of routine 2D ultrasound, contrast enhanced ultrasound (CEUS), and 3-dimensional (3D) ultrasound. TCDM, CEUS and 3D visualization of the carotid plaque improve the differentiation of stroke etiology and quantification of plaque vulnerability, and aid the prediction of future risk for cerebrovascular events in the individual patient.

AIMS: Assessment of prevalence and frequency of Microemboli signals (MES) in unselected patients with cerebral ischemia, the influence of antithrombotic drugs on MES, and the relationship between MES and recurrent stroke or Transient ischemic attack (TIA).

Categorization of atherosclerotic carotid artery disease by use of routine and advanced neurosonographic techniques combined with anamnestic and clinical data.

Development of a visualization solution tailored for 3D visualization of carotid arteries and semi-automatic plaque segmentation.

Read the detailed description
  • Standardized questionnaire
  • Extracranial and transcranial duplexsonography
  • Extracranial contrast-enhanced ultrasound
  • Extracranial 3D-ultrasound
  • Transcranial Doppler monitoring
  • Clinical work-up incl. radiological and cardiological procedures, scoring etc
02

Conditions studied

  • Ischemic Stroke
  • Carotid Artery Disease
  • Embolic Stroke
03

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with symptomatic and asymptomatic carotid artery disease admitted to the Dept. of Neurology at Haukeland University Hospital, Bergen/ Norway

Eligibility criteria

Inclusion Criteria:

  • Symptomatic carotid artery disease
  • Asymptomatic carotid artery disease
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
16 participants (actual)
Patient registry
No

Groups and cohorts

  • Symptomatic

    Symptomatic carotid artery disease

  • Asymptomatic

    Asymptomatic carotid artery disease

05

What researchers measure

Primary outcomes

  1. Ischemic stroke or TIA documented by Medical record

    Time frame: 3 months

Secondary outcomes

  1. Any arterial event documented by Medical record (composite)

    Ischemic stroke, TIA, Coronary artery disease, Myocardial infarction, Peripheral arterial disease

    Time frame: 3 months

06

Study locations

1 site
  • Haukeland University Hospital
    Bergen, 5021, Norway
07

References and documents

Publications

  • Aarli SJ, Thomassen L, Waje-Andreassen U, Logallo N, Kvistad CE, Naess H, Fromm A. The Course of Carotid Plaque Vulnerability Assessed by Advanced Neurosonology. Front Neurol. 2021 Aug 20;12:702657. doi: 10.3389/fneur.2021.702657. eCollection 2021. PubMed 34489850 ↗
08

Registry details

Key details

Study ID
NCT02759653
Lead sponsor
Haukeland University Hospital
Collaborators
University of Bergen
Responsible party
Sponsor
First posted
May 3, 2016
Start date
May 2016
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
Feb 15, 2021

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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